A Phase 1 Study in Healthy Subjects to Evaluate the Relative Bioavailability of Two Lutikizumab Formulations and to Evaluate Lutikizumab Pharmacokinetics, Safety, and Tolerability in Healthy Chinese Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 3
- 主要终点
- AUC from Time 0 to Infinity (AUC0-inf) of Lutikizumab
研究概览
简要总结
The purpose of this study is to compare the bioavailability of two different formulations of lutikizumab, and to assess adverse events (AEs) and how lutikizumab moves through the body in healthy Chinese participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female healthy volunteers aged between 18 and 60 years.
- •- Part 2 only: Participant must be first-generation Han Chinese of full Chinese parentage residing outside of China. Participant must maintain a typical Chinese lifestyle, including consuming a typical Chinese diet.
- •BMI <= 18.0 to <= 29.9 kg/m^2 after rounding to the tenths decimal, at screening and upon initial confinement.
- •A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile, and 12-lead electrocardiogram (ECG).
排除标准
- •Use any medications, vitamins, and/or herbal supplements within the 2 week period or 5 half-lives (whichever is longer) prior to study drug administration.
- •History of: epilepsy, any clinically significant cardiac, respiratory (except mild asthma), renal, hepatic ,gastrointestinal, hematologic, demyelinating disease (including myelitis) or neurologic symptoms suggestive of demyelinating disease, glaucoma, psychiatric disease or disorder, or any uncontrolled medical illness.
- •Prior exposure to lutikizumab.
研究组 & 干预措施
Part 1, Dose A
Participants will receive a single dose of Lutikizumab Dose A.
干预措施: Lutikizumab Dose A (Drug)
Part 1, Dose B
Participants will receive a single dose of Lutikizumab Dose B.
干预措施: Lutikizumab Dose B (Drug)
Part 2
Han Chinese participants will receive a single dose of Lutikizumab.
干预措施: Lutikizumab Dose A (Drug)
结局指标
主要结局
AUC from Time 0 to Infinity (AUC0-inf) of Lutikizumab
时间窗: Up to Day 8
AUC0-inf of lutikizumab will be assessed.
Number of Participants with Adverse Events (AEs)
时间窗: Baseline to Day 71
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Terminal Phase Elimination Half-life (t1/2) of Lutikizumab
时间窗: Up to Day 8
Terminal phase elimination half-life (t1/2) of lutikizumab will be assessed.
Time to Cmax (Tmax) of Lutikizumab
时间窗: Up to Day 8
Tmax of lutikizumab will be assessed.
Apparent Terminal Phase Elimination Rate Constant (β) of Lutikizumab
时间窗: Up to Day 8
Apparent terminal phase elimination rate constant (β) of lutikizumab will be assessed.
Maximum Observed Serum Concentration (Cmax) of Lutikizumab
时间窗: Up to Day 8
Cmax of lutikizumab will be assessed.
Area under the Serum Concentration-time Curve (AUC) from Time 0 to the Time of the Last Measurable Concentration (AUC0-t) of Lutikizumab
时间窗: Up to Day 8
AUC0-t of lutikizumab will be assessed.
次要结局
未报告次要终点